| 1. |
- Bianco, Paolo, et al.
(author)
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Regulation of stem cell therapies under attack in Europe: for whom the bell tolls
- 2013
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In: EMBO Journal. - : Wiley. - 1460-2075 .- 0261-4189. ; 32:11, s. 1489-1495
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Journal article (other academic/artistic)abstract
- At the time of writing, the Italian Parliament is debating a new law that would make it legal to practice an unproven stem cell treatment in public hospitals. The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations. This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation. The scientific community must consider the context-social, financial, medical, legal-in which stem cell science is currently situated and the need for stringent regulation. Additional concerns are emerging. These emanate from the novel climate, created within science itself, and stem cell science in particular, by the currently prevailing model of 'translational medicine'. Only rigorous science and rigorous regulation can ensure translation of science into effective therapies rather than into ineffective market products, and mark, at the same time, the sharp distinction between the striving for new therapies and the deceit of patients.
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| 2. |
- Koch, Philipp, et al.
(author)
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Emerging concepts in neural stem cell research: autologous repair and cell-based disease modelling
- 2009
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In: Lancet Neurology. - 1474-4465. ; 8:9, s. 819-829
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Research review (peer-reviewed)abstract
- The increasing availability of human pluripotent stem cells provides new prospects for neural-replacement strategies and disease-related basic research. With almost unlimited potential for self-renewal, the use of human embryonic stem cells (ESCs) bypasses the restricted supply and expandability of primary cells that has been a major bottleneck in previous neural transplantation approaches. Translation of developmental patterning and cell-type specification techniques to human ESC cultures enables in vitro generation of various neuronal and glial cell types. The derivation of stably proliferating neural stem cells from human ESCs further facilitates standardisation and circumvents the problem of batch-to-batch variations commonly encountered in "run-through" protocols, which promote terminal differentiation of pluripotent stem cells into somatic cell types without defined intermediate precursor stages. The advent of cell reprogramming offers an opportunity to translate these advances to induced pluripotent stem cells, thereby enabling the generation of neurons and glia from individual patients. Eventually, reprogramming could provide a supply of autologous neural cells for transplantation, and could lead to the establishment of cellular model systems of neurological diseases.
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